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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001137 |
Purpose
The purpose of this study is to determine what combinations of anti-HIV drugs work best in patients treated over several years. The study will also assess the occurrence of side effects and opportunistic infections in patients with low viral loads compared to those with higher viral loads.
| Condition |
|---|
|
HIV Infections |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Adult AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT) Protocol |
| Estimated Enrollment: | 4500 |
| Study Start Date: | January 2000 |
A compilation of outcomes of various antiretroviral therapies would be beneficial when evaluating which strategies are most effective in long-term treatment of HIV-1. Using data from present and recently completed studies, this study will collect information on therapies and their control of HIV infection and maintenance of durable suppression of HIV-1 replication.
No treatment is provided by this study, but patients will continue to receive highly active antiretroviral therapy (HAART) from other studies in which they are coenrolled. Blood and urine collection will occur at study entry and periodically throughout the study. Women may undergo pelvic exams and Pap smears. Portions of blood samples will be stored to evaluate genotypic/phenotypic susceptibility testing. Medical histories, physical exams, and questionnaires will be completed periodically.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Participants in this study will be HIV infected men and women who are enrolled in an ACTG parent study and are receiving HAART.
Inclusion Criteria
Exclusion Criteria
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Betty McCulloch 205-975-7925 bmcc@uab.edu | |
| United States, California | |
| Univ of California / San Diego Treatment Ctr | Recruiting |
| San Diego, California, United States, 921036325 | |
| Contact: Jill Kunkel 619-543-8080 jkunkel@ucsd.edu | |
| Univ of California, San Francisco/San Francisco General Hosp | Recruiting |
| San Francisco, California, United States, 94110 | |
| Contact: Michele Downing, RN 415-514-0550 ext 354 mdowning@php.ucsf.edu | |
| Stanford Univ Med Ctr | Recruiting |
| Stanford, California, United States, 943055107 | |
| Contact: Debbie Slamowitz 650-723-2804 dslam@leland.stanford.edu | |
| San Mateo AIDS Program / Stanford Univ | Active, not recruiting |
| Stanford, California, United States, 943055107 | |
| Univ of Southern California / LA County USC Med Ctr | Recruiting |
| Los Angeles, California, United States, 900331079 | |
| Contact: Luis Mendez 323-343-8283 lmendez@hsc.usc.edu | |
| Harbor UCLA Med Ctr | Recruiting |
| Torrance, California, United States, 90502 | |
| Contact: Sally Kruger 310-222-3848 KRUGER@AFP76.HUMC.EDU | |
| UCLA CARE Ctr | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Susan McCarthy 310-206-8029 smccarthy@mednet.ucla.edu | |
| Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium | Active, not recruiting |
| San Jose, California, United States, 951282699 | |
| Marin County Specialty Clinic | Active, not recruiting |
| San Rafael, California, United States, 94903 | |
| Willow Clinic | Active, not recruiting |
| Menlo Park, California, United States, 94025 | |
| Kaiser Permanente LAMC | Active, not recruiting |
| Los Angeles, California, United States, 90027 | |
| UC Davis Med Ctr | Active, not recruiting |
| Sacramento, California, United States, 95814 | |
| United States, Colorado | |
| Univ of Colorado Health Sciences Ctr | Recruiting |
| Denver, Colorado, United States, 80262 | |
| Contact: Graham M. Ray 303-372-5535 graham.ray@uchsc.edu | |
| United States, District of Columbia | |
| Georgetown Univ Med Ctr | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Candance Levy 202-687-5378 levycj@georgetown.edu | |
| United States, Florida | |
| Univ of Miami School of Medicine | Recruiting |
| Miami, Florida, United States, 331361013 | |
| Contact: Leslie Thompson 305-243-3841 thomps04@pop.fstrf.org | |
| United States, Georgia | |
| Emory Univ | Recruiting |
| Atlanta, Georgia, United States, 30308 | |
| Contact: Beth Dean 404-616-0654 tbdean@emory.edu | |
| Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr | Active, not recruiting |
| Atlanta, Georgia, United States, 303652225 | |
| United States, Hawaii | |
| Univ of Hawaii | Active, not recruiting |
| Honolulu, Hawaii, United States, 96816 | |
| Tripler Army Med Ctr | Active, not recruiting |
| Tripler Amc, Hawaii, United States, 96859 | |
| United States, Illinois | |
| Northwestern Univ Med School | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Baiba L. Berzins 312-695-5012 baiba@nwu.edu | |
| Rush Presbyterian - Saint Luke's Med Ctr | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Jan Fritsche 312-942-5865 jfrits@rush.edu | |
| Cook County Hosp | Active, not recruiting |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Indiana Univ Hosp | Recruiting |
| Indianapolis, Indiana, United States, 462025250 | |
| Contact: Beth Zwickl 317-274-8456 Bwzwickl@iupui.edu | |
| Methodist Hosp of Indiana / Life Care Clinic | Active, not recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Division of Inf Diseases/ Indiana Univ Hosp | Active, not recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| Univ of Iowa Hosp and Clinic | Active, not recruiting |
| Iowa City, Iowa, United States, 52242 | |
| United States, Louisiana | |
| Tulane Med Ctr Hosp | Active, not recruiting |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Johns Hopkins Hosp | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Rebecca Becker 410-955-4370 Becker.Becy@FSTRF.org | |
| Univ of Maryland, Institute of Human Virology | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Susan LaSalvia 410-706-2785 lasalvia@umbi.umd.edu | |
| United States, Massachusetts | |
| Harvard (Massachusetts Gen Hosp) | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Teri Flynn 617-726-3819 tflynn@partners.org | |
| Beth Israel Deaconess - West Campus | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Helen Fitch 617-632-0785 hfitch@caregroup.harvard.edu | |
| Boston Med Ctr | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Contact: Caress Grodman 617-414-3182 carrie.grodman@bmc.org | |
| Brigham and Women's Hosp | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Teri Flynn 617-732-6410 | |
| United States, Michigan | |
| Wayne State Univ. CRS | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Martha Farrough 313-745-4431 mfarrough@med.wayne.edu | |
| Principal Investigator: Rodger D. MacArthur, MD | |
| United States, Minnesota | |
| Univ of Minnesota | Active, not recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Hennepin County Medical Clinic | Active, not recruiting |
| Minneapolis, Minnesota, United States, 55415 | |
| United States, Missouri | |
| St Louis Regional Hosp / St Louis Regional Med Ctr | Active, not recruiting |
| St Louis, Missouri, United States, 63112 | |
| United States, Nebraska | |
| Univ of Nebraska Med Ctr | Recruiting |
| Omaha, Nebraska, United States, 681985130 | |
| Contact: Frances Van Meter 402-559-8163 fvanmete@unmc.edu | |
| United States, New Jersey | |
| New Jersey Medical School- Adult Clinical Research Ctr. CRS | Recruiting |
| Newark, New Jersey, United States, 07103 | |
| Contact: Nancy Reilly 973-972-1268 reillyna@umdnj.edu | |
| Principal Investigator: Sally Hodder, MD | |
| Cooper Univ. Hosp. CRS | Recruiting |
| Camden, New Jersey, United States, 08103 | |
| Contact: Carol Graeber 856-963-6891 Graeber-carol@cooperhealth.edu | |
| Principal Investigator: John Baxter, MD | |
| United States, New York | |
| Univ of Rochester Medical Center | Active, not recruiting |
| Rochester, New York, United States, 14642 | |
| Bellevue Hosp / New York Univ Med Ctr | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Maura Laverty 212-263-6565 maura.laverty@med.nyu.edu | |
| Mount Sinai Med Ctr | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Eileen Chusid 212-241-0433 CHUSID.EILEEN@FSTRF.ORG | |
| Cornell Univ Med Ctr | Active, not recruiting |
| New York, New York, United States, 10021 | |
| SUNY / Erie County Med Ctr at Buffalo | Active, not recruiting |
| Buffalo, New York, United States, 14215 | |
| Beth Israel Med Ctr | Recruiting |
| New York, New York, United States, 10003 | |
| Contact: Ann Marshak 212-420-4432 marshak.ann@fstrf.org | |
| Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Arlene Hurley 212-327-7281 HURLEYA@ROCKVAX.ROCKEFELLER.EDU | |
| Columbia Presbyterian Med Ctr | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Mykyelle Crawford 212-305-2665 mc675@columbia.edu | |
| Chelsea Ctr | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Brenda Greenhill 212-746-4177 | |
| Community Health Network Inc | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Carol Greisberger 716-275-5871 carol_greisberger@urmc.rochester.edu | |
| Bronx-Lebanon Hosp. Ctr. CRS | Recruiting |
| Bronx, New York, United States, 10457 | |
| Contact: Noemi Olivo 718-901-6346 nolivo@bronxleb.org | |
| United States, North Carolina | |
| Carolinas Med Ctr | Active, not recruiting |
| Charlotte, North Carolina, United States, 28203 | |
| Univ of North Carolina | Recruiting |
| Chapel Hill, North Carolina, United States, 275997215 | |
| Contact: Barbara Longmire 919-966-7883 LONGBAR@MED.UNC.EDU | |
| Moses H Cone Memorial Hosp | Recruiting |
| Greensboro, North Carolina, United States, 27401 | |
| Contact: Pam Mentley 910-574-7888 pam.mentley@mosescone.com | |
| Duke Univ Med Ctr | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Paulette MacDougall 919-668-0161 mcdou006@mc.duke.edu | |
| Wake County Department of Health | Active, not recruiting |
| Chapel Hill, North Carolina, United States, 27514 | |
| United States, Ohio | |
| Univ of Cincinnati | Recruiting |
| Cincinnati, Ohio, United States, 452670405 | |
| Contact: Tammy Powell 513-584-8373 powelltm@email.uc.edu | |
| Ohio State Univ Hosp Clinic | Recruiting |
| Columbus, Ohio, United States, 432101228 | |
| Contact: Judith Neidig 614-293-8112 NEIDIG.1@OSU.EDU | |
| MetroHealth Med Ctr | Recruiting |
| Cleveland, Ohio, United States, 441091998 | |
| Contact: Nancy Frantz 216-459-5136 | |
| Cleveland Clinic | Active, not recruiting |
| Cleveland, Ohio, United States, 44106-5083 | |
| United States, Pennsylvania | |
| Univ of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Christine Tripoli 412-647-0771 tripolica@msx.upmc.edu | |
| Univ of Pennsylvania at Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Christopher Helker 215-349-8092 chelker2@mail.med.upenn.edu | |
| Presbyterian Medical Center - Univ. of PA | Recruiting |
| Norristown, Pennsylvania, United States, 19401 | |
| Contact: Maureen T O'Connell, RN, BSN 215-349-8092 maureen.oconnell@uphs.upenn.edu | |
| United States, South Carolina | |
| Julio Arroyo | Recruiting |
| West Columbia, South Carolina, United States, 29169 | |
| Contact: Michael Klebert 314-454-0058 MKLEBERT@IMGATE.WUSTL.EDU | |
| United States, Tennessee | |
| Vanderbilt Univ Med Ctr | Active, not recruiting |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Univ of Texas, Southwestern Med Ctr of Dallas | Active, not recruiting |
| Dallas, Texas, United States, 75390 | |
| Houston AIDS Research Team CRS | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Robert C. Arduino, MD 713-500-6713 roberto.c.arduino@uth.tmc.edu | |
| Principal Investigator: Ben J. Barnett | |
| Principal Investigator: Roberto C. Arduino, MD | |
| United States, Washington | |
| Univ of Washington | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Jeanne Conley 206-731-8877 njc@u.washington.edu | |
| Puerto Rico | |
| Univ of Puerto Rico | Recruiting |
| San Juan, Puerto Rico, 009365067 | |
| Contact: Virginia Ramirez 787-767-9192 ramirez.virginia@fstrf.org | |
| Study Chair: | Constance A. Benson, MD | Division of Infectious Disease, Antiviral Research Center, University of California, San Diego |
| Study Chair: | Ann C. Collier, MD | University of Washington, Harborview Medical Center |
More Information
| Responsible Party: | DAIDS ( Rona Siskind ) |
| Study ID Numbers: | ACTG A5001, AACTG A5001 |
| Study First Received: | January 28, 2000 |
| Last Updated: | November 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00001137 History of Changes |
| Health Authority: | United States: Federal Government |
|
Treatment Experienced Treatment Naive Virus Replication AIDS-Related Opportunistic Infections HIV-1 Risk Factors Incidence |
RNA, Viral Anti-HIV Agents Viral Load Lipodystrophy Nervous System Cardiovascular System |
|
Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection |
Immunologic Deficiency Syndromes Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |